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Gebrauchsanweisung MPL 40

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					2 µm Medical Continuous Wave Laser




                                  RevoLix
                                             User manual




 LISA laser products OHG, D-37191 Katlenburg, Max-Planck-Straße 1, Tel. (49) 05556-9938-0, Fax (49) 05556-9938-10
                  34A03606-7992-4EEB-95E6-1D183F0A84FF.DOC – gedruckt / printed: 12.07.11
GA: User Manual RevoLix




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Contents

1     About this manual ............................................................................................. 7
      1.1 Safety instructions and symbols used in this manual ..............................................................7


2     Manufacturer ..................................................................................................... 9


3     Distributor in the United States of America .................................................. 11


4     Scope of this user manual ............................................................................. 13


5     Important customer information .................................................................... 15


6     General description ........................................................................................ 17
      6.1 Basic physico-technical principles .........................................................................................17
      6.2 Basic physico-medical principles ...........................................................................................18
      6.2.1 Comparison to flashlamp pumped lasers .........................................................................19
      6.2.2 RevoLix pulsed mode .......................................................................................................19
      6.3 Intended use of the RevoLix medical 2 µm continuous wave laser ......................................19
      6.3.1 Power setting ....................................................................................................................20
      6.3.2 Beam diameter at tissue ...................................................................................................20
      6.3.3 Fiber selection ...................................................................................................................20
      6.3.4 Contact versus non-contact mode ....................................................................................20
      6.3.5 Open surgery (gaseous medium) .....................................................................................21
      6.3.6 Laser surgery in aqueous medium....................................................................................21


7     Laser and device safety .................................................................................. 23
      7.1 Marking of entrance doors to laser areas ..............................................................................24
      7.2 Marking of the laser system ..................................................................................................25
      7.2.1 Laser Warning Labels .......................................................................................................25
      7.2.2 Beam outlet (fiber port) .....................................................................................................25
      7.2.3 Laserstop ..........................................................................................................................26
      7.2.4 Danger Label Electric Energy ...........................................................................................26
      7.2.5 Name Plate .......................................................................................................................26
      7.2.6 Identification of the Modules .............................................................................................27
      7.2.7 Distributor Label (USA) .....................................................................................................27
      7.2.8 Position of Labels ..............................................................................................................27
      7.3 Laser safety eyewear ............................................................................................................28
      7.3.1 NOHD - "Nominal Ocular Hazard Distance" for RevoLix Laser ........................................28
      7.3.2 Required eye protection ....................................................................................................29
      7.4 Laser safety officer ................................................................................................................29
      7.5 Authorized users of the laser system ....................................................................................29
      7.6 System book, medical systems book ....................................................................................30


8     Installation of the laser system ...................................................................... 31
      8.1   Transportation and storage of the laser system ....................................................................31
      8.2   Orderly state of the module latches .......................................................................................31
      8.3   Marking the operating room ..................................................................................................32
      8.4   Laser warning light ................................................................................................................32

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      8.5    Mains connection ..................................................................................................................32
      8.6    Cooling ..................................................................................................................................32
      8.7    Connecting the foot switch ....................................................................................................33
      8.8    Connecting a door interlock ...................................................................................................33


9     Operation of the laser system ........................................................................ 35
      9.1 Operating and display components .......................................................................................35
      9.1.1 Back of the system............................................................................................................35
      9.1.2 Front of the system ...........................................................................................................36
      9.1.3 Operating console .............................................................................................................36
      9.2 Attaching the laser fiber to the fiber port ...............................................................................37
      9.2.1 Checking the laser fiber for orderly state ..........................................................................37
      9.2.2 Connecting the fiber to the laser .......................................................................................37
      9.2.3 Disconnecting the fiber from the laser ..............................................................................38
      9.3 Start-up and switch-on routine ..............................................................................................38
      9.3.1 Operational states of the system ......................................................................................40
      9.4 Setting the laser parameters .................................................................................................40
      9.5 Status display on the monitor ................................................................................................41
      9.5.1 Operational mode selection ..............................................................................................41
      9.5.1.1 Setting the treatment parameters for continuous operation .........................................42
      9.5.1.2 Setting the treatment parameters for pulsed and single-pulse operation .....................43
      9.5.1.3 Setting the brightness of the pilot laser / aiming beam .................................................43
      9.6 Switch-off routine...................................................................................................................43
      9.7 Orderly state of the laser system ...........................................................................................43


10    Clinical applications ....................................................................................... 45
      10.1 Urology ...............................................................................................................................45
      10.1.1 Opening of urethral strictures............................................................................................46
      10.1.2 Opening of ureter strictures ..............................................................................................47
      10.1.3 Resection of the prostate ..................................................................................................48
      10.1.4 Bladder neck incisions ......................................................................................................49
      10.1.5 In-situ ablation of bladder tumors......................................................................................50
      10.1.6 Condylomata .....................................................................................................................51
      10.2 Gynecology ........................................................................................................................52
      10.2.1 Incisions and excisions to the outer female genital ..........................................................53
      10.2.2 Condylomata .....................................................................................................................54


11    Error messages ............................................................................................... 55
      11.1 Error menu .........................................................................................................................55
      11.2 List of error messages .......................................................................................................55


12    Care and maintenance .................................................................................... 57
      12.1      Cleaning .............................................................................................................................57
      12.2      Technical safety control and maintenance .........................................................................57
      12.3      Calibration of the energy and power displays ....................................................................57
      12.4      Use of the external power meter ........................................................................................57


13    Decontamination of Returned Equipment .................................................... 59


14    Technical data ................................................................................................. 61


15    Technical data RevoLix .................................................................................. 63


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16    Accessories for RevoLix ................................................................................ 65


17    Conformity declaration ................................................................................... 67


18    ISO certificates ................................................................................................ 71


19    Index ................................................................................................................. 77




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1 About this manual
This manual provides important information concerning the safe handling of the medical 2 µm
continuos wave lasers RevoLix.

This manual must be carefully read and comprehended before using the laser system for the
first time!

1.1       Safety instructions and symbols used in this manual

The safety instructions in this manual are intended to prevent possible injuries, material damage and
operational faults. The fact that, before operating the laser for the first time, you should read through
this manual carefully and keep it for future reference, is also considered to be part of the safe operation
of this product.

In this manual a distinction is made between the safety instructions used to warn of possible injury
(DANGER) and instructions warning against operational faults (WARNING):

DANGER:          Risk of injury! This instruction concerns the safety of patients, operators and other
                 persons, who are in the room, in which the laser is being operated or maintained.

                 In this manual the following symbol is used to warn of the risk of injury from laser
                 radiation (Fig. 1):




                                       Fig. 1: Symbol for Danger




WARNING:         Danger of operational fault! Failure to follow this instruction can lead to damage to
                 the laser system, the applicator or the laser fiber.

                 In this manual the following symbol is used to indicate a possible operational fault
                 and the damage to the laser system, which might result from it (Fig. 2).




                                      Fig. 2: Symbol for Warning




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2 Manufacturer
                                LISA laser products OHG
                                Max-Planck-Str. 1
                                37191 Katlenburg-Lindau
                                Germany
                                Fon:    +49-(0)5556-9938-0
                                Fax:    +49-(0)5556-9938-10
                                e-mail: info@lisalaser.de
                                web:    www.lisalaser.de




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3 Distributor in the United States of America
                                 AllMed Systems, Inc.
                                 9232 Klemetson Drive
                                 CA 94588 Pleasanton
                                 USA
                                 Fon:    +1 - 925 468 0433
                                 Fax:    +1 - 925 399 5984
                                 e-mail: pallen@allmedsys.com
                                 web:    www.allmedsys.com



CAUTION: US federal law restricts this device to sale by or on the order of a physician!




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4 Scope of this user manual
The regular scope of supply includes:
RevoLix laser system             qty.   items included
RevoLix 2 µm cw medical laser      1    RevoLix 2 µm cw medical laser
                                   1    Foot switch
                                   1    Door-interlock dummy connector
                                   1    User manual
                                   2    Laser warning signs
                                   3    Laser safety glasses




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5 Important customer information
This manual describes the medical 2 µm continuous wave lasers of the RevoLix series. The power
range (max. power) and the name of the laser in question is to be found on the name plate (Fig. 10).
The name of the laser appears on the start display (Fig. 20) after switched on.

The laser systems belongs to the following classifications/nomenclatures:
Medical product class according to MDD 93/42/EEC (Medical Device Directive)          Class IIb
Medical Device Class according to Title 21 of CFR, Parts 862-892                     Class II
Medical product nomenclature according to UMDNS                                      17-447
Laser class according to IEC 60825                                                   Class 4 / IV
Protection class according to IEC 60601                                              Class I
Protection group according to EN 60529                                               IP20
The RevoLix laser system complies with the ”Essential Requirements of the European Medical
Devices Directive 93/42/EEC”

Observe the applicable guidelines of your employer‟s liability insurance association and equal ranking
organizations. The responsibilities, relevant safety measures and personal protective gear are
described in these regulations.

Observe the specific national laws and regulations on operation and safety of medical devices
and laser equipment.

The installation of a laser system must be according to the instructions given in this manual.

The documents referred to and this manual must be read carefully before operating the laser
system.




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6 General description
The RevoLix medical 2 µm continuous wave laser is a high-performance, fiber coupled, diode pumped
solid state (DPSS) laser for medical use in surgery (Chap. 10 “Clinical applications”). The wavelength
is invisible infrared.

The RevoLix emits radiation at a wavelength of 2013 nm (equal to 2.013 µm). The radiation is given off
in the continuous wave (cw) mode. The cw emission may be chopped as well (Pulsed mode). However
the maximum pulse peak power remains the same as the set cw power.

The laser radiation is transmitted through a quartz glass fiber. The distal end of the fiber is attached to
a suitable applicator. Various applicators are available for clinical use, which are designed for a specific
purpose. The use and maintenance of the individual applicators is described in the respective
manuals.

Operation of the laser system is undertaken from an operating console using a display. Activating and
setting the operating parameters is described in the Section “Operation of the laser system”.

6.1       Basic physico-technical principles

The RevoLix laser systems are high-performance lasers. The solid state laser crystal is excited by
laser radiation emitted from a stack of semiconductor laser diodes. The diode laser radiation is
directed at the solid state laser crystal which emits the 2 µm laser radiation. The 2 µm laser beam is
focused into a fiber. The 2 µm laser radiation emitted from the fiber – guided by a suitable applicator or
focussing hand-piece – serves as the surgical instrument.

The laser-tissue-interaction is based on the strong absorption of 2 µm radiation by water molecules,
which are omnipresent in tissue disregarding coloration or circulation. The penetration of the RevoLix
laser beam into tissue is less than 0.5 mm assuming no change of the optical properties of the
irradiated tissue. The absorbing (= effected) volume of tissue is always within the visual reach of the
surgeon. This property makes this laser a safe and universal surgical tool for soft tissue surgery.


                                          1,0E+05


                                          1,0E+04


                                          1,0E+03
          Absorption Coefficient [cm-1]




                                          1,0E+02


                                          1,0E+01


                                          1,0E+00                                                           Nd:YAG
                                                                                                            RevoLix
                                          1,0E-01
                                                                                                            Ho:YAG
                                                                                                            CO2
                                          1,0E-02


                                          1,0E-03


                                          1,0E-04
                                                100                    1000                     10000                  100000
                                                                              Wavelength [nm]

                                                    Fig. 3: Absorption spectra of water with laser wavelengths




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6.2       Basic physico-medical principles

The effect of the 2 µm cw laser radiation to tissue depends on the intensity of the laser radiation.
Intensity is defined as power per area. Another common word for the same is power density. The
intensity may be varied by setting the power of the laser and/or selecting the distance from the tip of
the fiber to the tissue. The distance dependence is due the fact that the radiation diverges considerably
on emerging from the fiber.

Additionally the tissue effect depends on whether the procedure is carried out in open surgery (ambient
= gas) or in an aqueous medium. In a gaseous medium the generated heat is converted into
evaporation and dissipates into the adjacent tissue. Only very little heat is taken away by the ambient
gaseous medium. Some smoke may be generated which is easily removed by a smoke evacuator.

An aqueous medium is advantageous twofold: There is much better cooling provided to the treated
tissue which prevents charring. Furthermore any tissue which is more than 5 mm distant from the tip of
the fiber is shielded off by the strong absorption of the laser radiation into the aqueous medium.

At low intensities (low power setting and/or larger spot diameter at tissue) the effect to tissue is mainly
coagulative because the density of the absorbed power is less than required for the evaporation of
water within the tissue. The effect to the tissue will be limited to a noticeable blanching. Even prolonged
irradiation does not lead to evaporation, because the absorption process of the laser radiation is
superimposed by the dissipation of heat into the surrounding medium (tissue, ambient gas or medium).
In other words: the cooling effect by heat conduction into the ambient overcomes the heat build up due
to absorption (I in Fig. 4).

With the intensity increasing (higher power setting and/or smaller spot diameter) the temperature of the
irradiated tissue increases. At some point the heat build up inside the irradiated tissue reaches a point
where the water in the tissue evaporates and takes it away (Is in Fig. 4).




                          Fig. 4: Tissue effect depending on power density

The evaporation may be controlled to some extent by varying the power density (II in Fig. 4).

However at some point (III in Fig. 4) further increase of the power density does not lead to an increase
of evaporation because the tissue is shielded off by evaporation products.

If the fiber is kept in place the evaporation of tissue will continue until the tissue has retracted and the
critical intensity for ablation is under passed. Some charring of the tissue will occur when using the
laser in open surgery. In aqueous medium charring is strongly reduced.




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6.2.1   Comparison to flashlamp pumped lasers

Flashlamp pumped lasers like Holmium lasers by nature emit laser radiation in a pulsed mode. The
average power of these lasers is defined as the product of the pulse energy [Joules] multiplied by the
pulse repetition rate [Hertz].

However the pulse peak power of free running flashlamp pumped lasers like Holmium YAG always is
in the kilowatt range [kW] - even at the lowest power setting of the laser which may be a few watts only.
The high intensity generated by each laser Holmium laser pulse evaporates all kinds of tissue -
regardless if soft or hard like bone or stone. The downside of the pulsed radiation are ruptures and
traumas to the surrounding tissue, bubble formation impairing the visibility, sputtering of tissue
fragments and soiling of endoscope lenses when used in open surgery.

The RevoLix 2 µm cw laser emits laser radiation in a continuous mode. The available power range
depends on the specific model. As a result the coagulative and ablative tissue effects are gentle
compared to the flash lamp pumped laser. The tissue is coagulated or dissected with no trauma,
visibility is not affected by bubbles, no tissue fragments including living cells sputter lenses or masks.

6.2.2   RevoLix pulsed mode

The RevoLix may be operated in a pulsed mode as well. However the pulse peak power of the 2 µm
cw laser always is of the same power [Watts] as indicated of the display of the console. The single and
repetitive pulsed mode is included into the specification of the laser in order to give a better control on
the laser emission to the surgeon.

Different to the pulsed Holmium YAG laser bubble formation in an aqueous medium in front of the
fiber, which guides the divergent beam to tissue (Moses effect does not occur).

The pulsed mode of the 2 µm cw laser radiation is incapable of ablating hard tissue like bone and
stone.

6.3       Intended use of the RevoLix medical 2 µm continuous wave laser

The RevoLix is a surgical laser, which is used in the contact and non-contact mode for the incision,
excision, removal and coagulation of soft tissue. The underlying principle is the absorption of 2 µm
laser radiation by water molecules in tissue. The generated heat may by used for coagulation or
ablation of tissue depending on the treatment method applied.

The absorption of laser power is confined to a volume between the surface and a layer app. 0.5 to
1 mm below tissue. Tissue damage to lower lying tissue may occur due to heat conduction when the
fiber or beam is moved slowly or held in place.

The damage zone exceeds the visible excision by the optical penetration depth, which is of the, since
the laser energy penetrates beyond the excision further into the tissue. In addition there is heating of
the surrounding tissue, because heat is being dissipated by thermal conduction from the area, in which
the laser energy was absorbed.

The actual damage zone depends on the treatment technique. At a power density, which allows to cut
the tissue, the damaged zone is less than 1 mm. If the As a rule of thumb one can say: the longer the
applicator is held in one place, the more extensive is the zone of thermal damage.




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The following treatment parameters are to the surgeon‟s disposal:

Parameter                  Range                                                Effect

Power setting              High or low power                                    Speed

Beam diameter at           Contact or non-contact mode                          Beam intensity
tissue

Fiber selection            Different core and cladding diameter                 Beam intensity and fiber
                                                                                flexibility

Atmosphere                 Open surgery (gaseous) or in aqueous medium          Cooling and shielding

6.3.1   Power setting

The power setting determines how much tissue may be coagulated or evaporated per unit of time.
Because the RevoLix lasers show a very strong tissue effect the power should not be set too high for a
start. Please refer to the settings in the section “Clinical applications”.

6.3.2   Beam diameter at tissue

The laser beam emerging from the fiber / handpiece is divergent at a full cone angle of app. 25°. The
beam diameter increases with distance. As the laser beam intensity equals laser power divided by
beam cross section the beam intensity decreases with distance.

The laser intensity is highest at the distal tip of the fiber / handpiece and decreases with distance.

Evaporation of tissue requires high beam intensity. Reduced intensity is used for coagulation.

In aqueous medium the laser beam is strongly absorbed. Depending of the power setting tissue more
then 1 to 4 mm from the tip of the fiber is shielded of completely from the laser radiation. This feature
may be understood as a safety feature.

6.3.3   Fiber selection

A range of laser fibers is available for this laser (Section accessories). These fibers differ in core
diameter and in the outer (cladding) diameter.

The diameter of the optical core determines the highest achievable intensity at the distal tip of the fiber.
The smallest fibers achieves the highest intensity. However this effect is superimposed by the
divergent characteristic of the beam emerging from the fiber – meaning that after a short distance the
intensity from a 356 µm fiber is at the same level as the beam emerging from a 600 µm fiber.
Additionally it needs to be understood that small diameter fibers mechanical are more delicate than
“larger” fibers.

Most important for fiber selection is the compatibility with the instrument / applicator to be used and the
mechanical properties required for a special treatment. Please refer to the section “Clinical
applications”.

6.3.4   Contact versus non-contact mode

The effect of the laser is at its maximum directly in front of the fiber tip. Because of the divergence of
the laser beam emerging from the fiber, the diameter of the laser beam increases continuously with the
distance from the fiber tip. At the same time the intensity and, consequently, the effect of the laser
beam to tissue decreases.

Generally spoken the laser fiber will be used in contact mode if cutting or evaporation of tissue is
intended. For coagulation the fiber is retracted in order to decrease the intensity. It should be


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understood that in an aqueous medium the optical pathway of the laser is very short because of the
strong absorption of the 2 µm radiation in water.

6.3.5   Open surgery (gaseous medium)

In an air or gaseous medium there is very little cooling to the tissue despite conduction cooling by
adjacent tissue. Evaporation will take place rapidly as soon as the beam intensity reaches evaporation
threshold. Charring may be inevitable mainly with larger cuts in air. In Carbon Dioxide charring is less
because of the lack of Oxygen.

In a gaseous medium the diameter of the laser beam – and its intensity – can be controlled by the
distance between fiber tip and tissue because the gaseous atmosphere does not absorb the 2 µm
laser radiation. The full range between contact mode and non-contact mode is available in open
surgery.

Generated smoke may be controlled by means of a smoke evacuator.

6.3.6   Laser surgery in aqueous medium

In an aqueous medium there is ample cooling to the tissue surface under laser irradiation. Charring will
only be very limited, because the temperatures increase will be capped by the evaporation temperature
of the tissue and the aqueous medium (app. 100°C). Therefore higher power settings can be applied in
an aqueous medium compared to gaseous media for two reasons:

1. Compared to open surgery cooling is stronger, more power is required to achieve the desired effect;
2. Compared to open surgery charring is less.

In a aqueous medium the 2 µm laser radiation is strongly absorbed. Different to the pulsed Holmium
YAG laser bubble formation in front of the fiber, which guides the divergent beam to tissue (Moses
effect), does not occur.

The control on the beam diameter by the distance between fiber tip and tissue is limited because of the
strong absorption of the 2 µm laser radiation in the aqueous medium.

It does not matter whether the aqueous medium is a Glycine or Sodium Chloride solution. Both media
will provide very similar absorption and cooling characteristics.




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7 Laser and device safety
The RevoLix laser uses as the working beam a DPSS laser with an emission wavelength of 2 µm.
According to IEC 60825 this laser is class 4. Irradiation of persons can cause injuries to the skin and
eyes.

Internally a high power diode laser is used as an excitation source for the 2 µm cw laser. Several
technical precautions are provided to keep the accessible laser diode radiation at harmless level even
under fault condition.

A semiconductor laser with an emission wavelength of 635 nm and an output of < 1.0 mW is used as
an aiming beam (pilot laser). Although this laser is class 2, one should refrain from irradiating persons
when they are not undergoing treatment.

Observe the applicable national guidelines of your employer‟s liability insurance association and equal
ranking organizations and your national guidelines / regulations on the safe use of medical laser
devices. The responsibilities, relevant safety measures and personal protective gear are described in
these regulations.

                  Only use the laser for the purpose, for which it was designed!

                  Never point the laser beam at a person!

   DANGER         Irradiation of persons can cause injuries to the skin and eyes.

                  All persons in the laser area must wear appropriate laser safety eyewear.



                  Irradiation of flammable materials or liquids can cause them to ignite.

                  The laser system must not be used in an explosive atmosphere.

   DANGER



                  Smoke generated by laser tissue interaction may contain viable tissue particles or
                  toxic substances!

                  Use an appropriate smoke evacuation.
   DANGER



                  The function of the RevoLix may be affected by mobile or cordless phones and
                  other HF–communication devices.

                  Do not use mobile or cordless phones and other HF–communication devices
   DANGER         during operation of the RevoLix.


Follow the instructions in this manual and those in the laser accessory manual.




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7.1      Marking of entrance doors to laser areas

All entrance doors to the operating theatre (=laser area), in which the laser system is set up and
operated, are to be marked on the outside with the following warning sign in accordance with
IEC 60825 (or the relevant local regulation) (original black on yellow).

If a laser is used the operating theatre becomes the laser area.




                        Fig. 5: Warning sign for marking of entrance doors

A laser warning light above the entrance door to the operating room is compulsory. This light always
has to be illuminated when the laser is in operation.




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7.2      Marking of the laser system

This Chapter describes the type and the location of the danger and regulatory compliance labels of the
RevoLix laser. From the labeling of the system the user gets important information regarding the
device and the safety of laser devices. The labeling has to follows the applicable standards and
regulations.

7.2.1   Laser Warning Labels

The following signs are is attached to the back of the laser, (original black on yellow). They shows the
laser class and output. (Fig. 6)




Warning Label Laser Class               Warning Label Laser Output




                                        Warning Label Laser Output (USA only)

                                       Fig. 6: Laser Danger Label
7.2.2   Beam outlet (fiber port)

The beam outlet is marked with the following sign (original black on yellow)




                                   Fig. 7: Warning Labels Beam outlet



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7.2.3   Laserstop

The Laser Stop-Button is marked with the following sign (original black on yellow)


                                               Laser


                                                Stop
                               Fig. 8: Marking of the Laser-Stop Button

7.2.4   Danger Label Electric Energy

Parts of the device where danger from electric energy may occur are labeled with the following sign:




                                              DANGER
                                              HIGH VOLTAGE

                                    Fig. 9: Danger Label Electricity

7.2.5   Name Plate

The name plate is attached to the outside of the back door. It comprises all the necessary data for the
identification of your laser system (Fig. 10).



                                              RevoLix
                                                230 VAC, 1~/N/PE, 50/60 Hz,
                                                max. 16 A
                                Wavelength:     2.0 µm (Pilotlaser: 635 nm)
                                Max. Power:
                                Laserclass:    IV (Pilotlaser: II)
                                Serial No.:     SN XXX

                                                               IP20
                                                200X
                                                LISA laser products OHG
                                                Max-Planck-Str. 1
                                                D-37191 Katlenburg-Lindau
                                                Fon: +49 5556 99380

                                     Fig. 10: RevoLix Name Plate




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Attention, read   Manufacturing            Type BF         Ingress                 CE Marking             Serial Number
manual            date                     Applied part    protection

7.2.6   Identification of the Modules

The modules are marked by the name plates as shown below:

                                                          S/N
                        MCL RevoLix                             LISA laser products OHG
                                                                Max-Planck-Str. 1
                          Laser Module          2003            D-37191 Katlenburg-Lindau




                                                          S/N
                        MCL RevoLix                             LISA laser products OHG
                                                                Max-Planck-Str. 1
                          Power Module          2003            D-37191 Katlenburg-Lindau




                                                          S/N
                        MCL RevoLix                             LISA laser products OHG
                                                                Max-Planck-Str. 1
                          Chiller Module        2003            D-37191 Katlenburg-Lindau




                                                          S/N
                        MCL RevoLix                             LISA laser products OHG
                                                                Max-Planck-Str. 1
                       Equipment Module         2003            D-37191 Katlenburg-Lindau



                                     Fig. 11: Marking of the Modules

7.2.7   Distributor Label (USA)




                                     Fig. 12: Distributor Label (USA)

7.2.8   Position of Labels




                                                                                    Beam outlet (Fig. 7)




                                                                                            Laserstop (Fig. 8)



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                               Fig. 13: Labels at the front of the device




                                                                             N C
                                                                              E K
                                                                               R
                                                                               L
                                                                             IT O
                                                                             Remote Interlock
                                                                             receptacle




                                                                             USA Distributor
      Name Plate (Fig. 10)                                                   Label (Fig. 12)



                                                                             Danger Label
                                                                             Key switch
         Label Laser Class                                                   Laser (Fig.
                                                                             (off / on) 6)
         (Fig. 6)




                               Fig. 14: Labels at the back of the device



                                               N C
                                                E K
                                                 R
                                                 L
                                               IT O



                       Key switch (off / on) Remote Interlock   Footswitch
                                             receptacle         receptacle

7.3        Laser safety eyewear

7.3.1     NOHD - "Nominal Ocular Hazard Distance" for RevoLix Laser

As laser radiation is more or less divergent the energy density decreases with increasing distance from
the laser source. The NOHD marks the distance were the energy density of the laser radiation is equal
to the MPE (Maximum Permissible Exposure Limit).

The NOHD is calculated according to the European standard DIN EN 60825-1:2001-11 „Safety of laser
devices“.



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Wavelength                            λ = 2,01 µm

Numerical aperture of fiber           NA = 0,22

                                       = 25,4° = 0,443 rad

Fiber diameter                        a = 365 µm

Average power                         P0 = 100 W

time basis                            t = 10 s
                                               0,25        -2
MPE (Maximum Permissible              5600 t          Jm
Exposure Limit)
                                                      -0,75        -2              -2
EMPE =                                5600 (10 s)               W m = 995,83 W m

                                                                 4 P0
                                                                       a
                                                                E MZB
                                          NOHD 
                                                                   
NOHD = 0,81 m

Therefore the NOHD for the RevoLix is: 0.81 m.

7.3.2    Required eye protection

The laser area is considered to be that area, in which the amount of radiation or the radiation can
exceed the current maximum permitted radiation of the cornea of the eye (MPE), including the
possibility of a random unintended deviation of the laser beam. Usually the laser area is identical to the
room, in which the laser is installed. The worst case Nominal Ocular Hazard Distance (NOHD) of the
RevoLix laser is 0.8 m.

All personnel who are within the NOHD are considered to be within the laser area and shall wear
suitable eye protection supplied by the manufacturer/distributor of the laser system with a minimum
protection class (acc. to EN 207) of: L2 (at 2.01 µm)

7.4       Laser safety officer

According to most of the national regulations the operator – in most cases the hospital administration
or the qualified doctor – has to appoint in writing a proficient person to act as the laser safety officer for
the operation of the laser system.

The laser safety officer is regarded as proficient if, during his professional training or experience he
has acquired sufficient knowledge about the use of the laser, which is to be brought into use, and is
thoroughly informed about the effect of laser radiation, about safety measures and safety regulations,
so that he is able to assess the necessary safety precautions and check their effectiveness.

Make sure that you fulfill you national regulation on the safety of medical laser devices before operating
the system.

7.5       Authorized users of the laser system

The laser system may only be used by such persons who have been instructed by the manufacturer or
by an authorized representative of the manufacturer in the correct operation of the system taking the
manual into account. Only those people may receive instruction who, because of their knowledge or
practical experience, are suitable for instruction in the operation of this system. The RevoLix laser
system is intended solely for physicians trained in the use of the laser system.

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7.6      System book, medical systems book

Due to regulation in some countries a medical systems book is to be kept with the laser system. The
medical systems book is to be kept both by the operator as well as by the maintenance and servicing
personnel and it has to be shown on request to the competent testing and supervisory authorities.

The following is to be specially entered into the medical systems book:

1.      Training of the personnel responsible for the laser system
2.      Training of skilled operators
3.      Technical safety controls
4.      Maintenance measures and
5.      Functional errors.

The medical systems book is to be kept without gaps until the system is finally taken out of service and
to be kept for a further 5 years beyond that time.

Please make sure that you follow the applicable regulation in your country.




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8 Installation of the laser system
The laser system and the relevant local regulations impose specific requirements upon the installation
site. These requirements are for safety precautions, electrical supply and heat management.

The installation of the laser system needs to be carried out by an expert authorized by the system
manufacturer. This person will also carry out a functional test after the laser system has been installed
at the designated site.

The expert will also check and take care that all latches connecting the laser modules are orderly
connected and attached.

8.1      Transportation and storage of the laser system

During transportation and operation of the RevoLix, care must be taken to ensure that the system is
not subjected to severe jolts or vibrations.

If there is danger that the ambient temperature may drop to below +3°C, the cooling water must be
drained from the system and the laser head has to be purged with clean pressurized air of no more
than 3 bars for at least 5 minutes.

Before putting the laser back in operation new cooling water supplied by the laser manufacturer must
be filled up. Both the draining as well as the filling of the laser system with cooling water may only be
undertaken by an expert authorized by the system manufacturer. Operating the laser system without
cooling water may lead to severe damage to the laser diode.

The room temperature at the installation and storage locations must be at least +3 °C.


                  Severe jolts, vibration and ambient temperature of below + 3 °C, as well as
                  operating the laser system without cooling water can cause severe damage.


  WARNING


8.2      Orderly state of the module latches

The laser system consists of three modules, which separate at the seams visible at the side faces. The
modules interlock by 4 module latches at each end of the laser system. The module latches are
accessible, after opening the storage and service hatch. All latches have to be orderly locked at all
times. If the latches are open the hatches will disconnect from the laser system and the modules may
disconnect resulting into severe injuries to persons or serious damage.

                  Severe injuries and serious damage may occur if module latches are not properly
                  secured.


  WARNING


Fig. 15 shows the order state of the module latches. Fastening the module latches should be done
only by authorized personnel.




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                              Fig. 15: Orderly state of the module latches

8.3       Marking the operating room

The room, in which the laser system is to be operated, must be marked as a laser area in accordance
with the valid local regulation. The sign to be used for this is shown in section 7.1 ”Marking of entrance
doors”.

8.4       Laser warning light

The operator must install a laser warning light above the entrance door to the operating room. This
light must always be illuminated when the laser is in operation.

The manufacturer of the laser system or his representative will help with the electric wiring.

8.5       Mains connection

The RevoLix requires single phase mains supply (230 Volts, -13 %, +10 %, 16 Amps, 50/60 Hz). The
exact requirements for the laser system in question can be seen from the name plate.

8.6       Cooling

The RevoLix medical 2 µm continuous wave lasers are equipped with integrated refrigerant cooling
systems.

During operation of the laser the cooling system draws off the excess heat into the ambient air. The
heat load is specified in the section “Technical data”.

In rooms, which are not air-conditioned, one should take account of a corresponding warming of the
ambient air. The laser may be operated continuously at an ambient temperature of up to about 28 °C.
The system switches off automatically if the ambient temperature becomes too high (section 11 “Error
messages”)

There is no danger to the laser unless it switches off automatically.

The ventilation openings at the side faces of the laser system must not be covered during operation of
the laser system.

An additional cold water or gas connection is neither necessary not provided.




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8.7      Connecting the foot switch

The connector at the free end of the foot switch cable is plugged into the lower socket next to the Laser
Stop button at the front of the system (Fig. 17) and screwed tight. The storage hatch may be opened
for the operators ease. The connector will fit in only one orientation. All electrical connections to the
laser system are designed so that they are not interchangeable.

For safety and ease of control the foot switch and the distal end of the laser fiber always should be as
close as possible to each other and under control of the same person.

8.8      Connecting a door interlock

A door interlock may be plugged into the socket on the back side of laser system (Fig. 1: Back of the
system) and screwed tight. The installation of the door-interlock must be done in collaboration between
one of the manufacturer‟s service technicians and your house technician.

If no door interlock switch is used, the dummy connector supplied with the laser on delivery must be
plugged into the free socket. The dummy connector is fitted with an electrical bridge between pin 1 and
pin 3.

When the door-interlock switch circuit is open – or pin 1 and pin 3 are not bridged – the laser is
immediately de-activated. After the door-interlock switch has been closed again the laser can only be
operated again after pressing the „ready‟ button.




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9 Operation of the laser system
In the first part of this section the operating components of the laser system will be explained, without
the laser system having to be operated in order to understand the text.

The actual ”Start-up and switch-on routine” is described below in sub-section 9.2. In that sub-section it
will also be shown how the orderly state of the laser system can be ascertained.

Before using the laser system make sure that all safety measures have been taken.

If laser has been stored at an ambient temperature outside the “Operational ambient temperature”
range the laser needs to stored at “Operational ambient temperature” for at least 3 hours.

9.1       Operating and display components

The operating and display components are arranged in three groups, which are to be found at the front
and at the back of the system and on the operating console.

9.1.1    Back of the system

Mains supply, door-interlock and the service hatch is located at the back of the system.




                                                                                4



                                                                                 3

                                                                                 2




                                                                                1




                                       Fig. 16: Back of the system



1     Mains cable                  3    Key switch

2     Door-interlock connection    4    Service hatch




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9.1.2   Front of the system

Beam outlet, foot switch connection, Laser Stop button and the storage hatch are located at the front of
the system. The storage hatch opens just by pulling the opening close to the Laser Stop button.




                                                                                4



                                                                                1

                                                                                2



                                                                                3




                                     Fig. 17: Front of the system



1   Laser Stop button    3    Storage hatch (open)

2   Foot switch          4    Beam outlet with beam lock
    connection

With the storage hatch open there is access to the pigeon-hole for the foot switch and this “User
manual” inside the door.

9.1.3   Operating console

All communication between the operator and the laser is accomplished via the adjustable operating
console. The operating console swivels 180°.

The operating console comprises a b/w display, the laser warning lamp and a loudspeaker.

The input components are the two function buttons (menu button (1) and parameter selection button
(5)), the adjusting wheel (4) and the ready button (3).




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              2                                                                        3


               1


                                                                                        4

                    6


                                       Fig. 18: Operating console
                                                                                5
1     Menu button                 4   Adjusting wheel

2     Laser warning lamp          5   Parameter selection button

3     Ready button                6   Display

9.2        Attaching the laser fiber to the fiber port

9.2.1    Checking the laser fiber for orderly state

Before connecting the fiber the following points must be checked:

1.    The free-standing fiber tip in the fiber connector (ca. 0.5 mm in diameter, depending on fiber type)
      must be smoothly reflective and free from damage and dirt. The hollow space within the fiber
      connector surrounding the fiber tip must be free of any sign of blackening or burning. If necessary
      a magnifying glass must be used for checking.

2.    The fibers must be undamaged and without kinks throughout the entire length.

9.2.2    Connecting the fiber to the laser

1.    Check the orderly state of new fibers and the connector (see above).

2.    Open the beam lock (Fig. 17) by gently pushing the top downwards until the fiber port is fully
      opened. Carefully insert the fiber connector without applying force, feel the insertion, screw it in
      until it is finger-tight .




                                       Fig. 19: Connecting the fiber




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9.2.3    Disconnecting the fiber from the laser

1.    Unscrew the connected fiber connector from the beam outlet (turn to the left) and carefully take it
      out.

2.    Check the orderly state of the fiber (see above).

3.    Replace the protective cap to the connector and finger-tighten it.

                   Prevent all damage to the fiber connector. Damage to the fiber can lead to
                   absorption of laser power, heat build-up and destruction of the fiber connector and
                   the laser optics.

     WARNING
Please read the instructions for checking the laser fiber in the laser fiber manual. Damaged fibers
cannot be used any longer !


                   Replacing the fibers must not take place in the „ready‟ operational state (laser
                   warning lamp is switched on)!


     WARNING


                   The use of damaged fibers can lead to injuries because the laser radiation can be
                   emitted at the damaged point and not at the distal end of the fiber.


      DANGER

Instructions for cleaning and sterilizing the fibers can be found in the relevant accessory handbook.

9.3        Start-up and switch-on routine

Before switch on of the laser it is necessary to check whether:

the necessary safety precautions (7 “Laser and device safety”) have been taken

4. the foot switch is attached and the laser system is connected to a suitable power supply.

5. if necessary the door-interlock dummy connector is connected,

6. a laser fiber is connected or the beam lock is closed,

7. the necessary laser fibers and laser applicators are to hand and

8. all persons present in the laser area are wearing appropriate laser safety goggles. Take care that
   the laser safety goggles are suitable for the emitted wavelength and do not show signs of damage.


                   Irradiation of the eyes by direct or indirect laser radiation can lead to injuries and
                   irreversible damage to the eyes. All persons present in the laser area must wear
                   appropriate laser safety goggles.

      DANGER

Concerning the use of laser fibers and laser applicators please consult the manual for the accessory in
question.


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Switch-on routine:

1.   Switch on the laser system using the key switch on the back of the laser (1/4 turn to the right
     (clockwise)). It takes about 3 seconds for the first pumps and fans to start.

2.   The microprocessor control carries out various checks on the system during the first few seconds
     after switch-on (start-up). The start display (Fig. 20) appears on the monitor displaying the brand
     name. After completion of the start-up a tune is heard and the laser parameter menu appears on
     the screen (Fig. 21) (section 9.4 ”Setting the laser parameters”).




                         Fig. 20: Start display after switch on the laser system

Possible error messages during the start-up routine appear on the screen in clear text (Section 11
“Error messages”).

3.   The desired operational mode or the system menu is selected with the menu button (Section 9.1.3
     ”Operating console”).

4.   After activating the 'Ready' button the laser is switched from ”Stand by” state to ”Ready” state.
     The ”Ready” state is indicated by the illumination of the laser warning lamp on the console and
     the pilot laser being switched on. Should the pilot laser on the distal fiber end not be visible, then
     the setting for the brightness of the pilot laser (Section 9.4 ”Setting the laser parameters”) should
     be adjusted.

5.   There is a safety delay of 2 seconds after pressing the ”Ready” button, until the laser gets in the
     ”Ready” state. Only then it is possible to activate laser emission by activating the foot switch.
     Before activating the foot switch, make sure that the displayed parameter settings conform with
     the desired treatment parameters. Immediately on pressing the foot switch laser radiation will be
     emitted from the fiber. At the same time an audible signal is activated.


                  There is a danger of injury from uncontrolled emission of laser radiation. Only use
                  the laser system and the laser radiation for intended purposes.

                  Only with a laser fiber connected the “Ready state” can be activated.
     DANGER


6.   Before the laser is used on a patient, the user must become conversant with the orderly state of
     the laser system (Section 9.7 ”Orderly state of the laser system").




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9.3.1   Operational states of the system

During operation two different operational states are possible:

1. Stand-By: The system is fully operational but is not yet ready to emit laser radiation. The laser
warning lamp (No. 2 in and the pilot laser are not yet switched on. This state is reached after the start-
up.

2. Ready: By activating the „ready‟ button once (No. 3 in Fig. 18) the system is switched from the
Stand-By state to the Ready state (takes 2 seconds waiting). The system is now ready to emit laser
radiation. The laser warning lamp is lit and the pilot laser is switched on. By pressing the foot switch
laser radiation is emitted. Activating the „ready‟ button again switches the system back into Stand-By
state.

9.4        Setting the laser parameters

Setting the laser parameters is done by using the buttons and the adjusting wheel. After the laser
system has been switched on and completion of orderly start-up, the parameter menu appears on the
display (Fig. 21).




             Fig. 21: Parameter menu after switch on the laser system (Power setting 45 W)

The following abbreviations are used:

Power (or Max.Power) Power of the 2 µm laser power available from the distal end of the handpiece
                     or the fiber at this setting.

CONTINUOUS                The laser power is emitted continuously.

PULSED                    The laser power is not continuous but given off at set intervals.

SINGLE                    Only one single pulse given off.

Duration                  Pulse duration at this setting (ON TIME).

Repetition                Pulse repetition rate at this setting (how often the pulse is emitted per
                          second)




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 9.5       Status display on the monitor

 As part of the parameter menu in the lower left corner the status display (Fig. 22) shows details of the
 operational status of the system, together with the system time and date.




: No foot switch                                                                    : No fiber connected
connected                                                                            FI: Fiber is connected
D: Digital foot switch
connected



FS: Foot switch                                                                    : Laser in Stand-by
pressed,                                                                           RDY: Laser in Ready
Laser activated                                                                    mode
                            Fig. 22: Status display (extract from the display)




 9.5.1    Operational mode selection

 The RevoLix laser may be operated in continuous mode, pulsed mode and single pulse mode.

 By pressing the menu selection button (No.1 in Fig. 18) left to the display, it is possible to toggle
 between CONTINUOUS operation (Fig. 23), PULSED operation (Fig. 24), SINGLE pulse operation
 (Fig. 25) and the SYSTEM menu (Fig. 26). The selected mode is highlighted in white.




                             Fig. 23: Parameter menu for continuous mode




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                              Fig. 24: Parameter menu pulsed mode




                        Fig. 25: Parameter menu for single pulse operation




                                  Fig. 26: RevoLix system menu

9.5.1.1        Setting the treatment parameters for continuous operation

In continuous wave (cw) operation the output power is set by adjusting the wheel between minimum
and the maximum power. These values depend on the model and are listed in the specifications.
Turning the adjusting wheel (No. 4 in Fig. 18) to the right (clockwise) increases the maximum power;
turning the adjusting wheel to the left (counter-clockwise) decreases the maximum power.

On adjusting the POWER the system falls back to “STAND BY”. After setting the power the “Ready
Button” has to be presses again for “READY”.



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9.5.1.2          Setting the treatment parameters for pulsed and single-pulse operation

Repeated pulsed mode operation is selected by pressing the parameter selection button (Fig. 18, No.
5) until PULSED is highlighted. In this mode POWER (pulse peak power), Duration (pulse duration)
and Repetition can be selected. The parameter selected is highlighted in white and can be altered with
the adjusting wheel. Turning the adjusting wheel to the right (clockwise) increases the selected
parameter; turning the adjusting wheel to the left (anti-clockwise) decreases the selected parameter.
By turning the adjusting wheel to the left (counter-clockwise) the counter is set to zero. The pulse
duration can be adjusted from 50 -1000 ms in 10 ms intervals. The repetition rate can be set from 0.5 –
10 Hz in steps of 0.5 Hz.

The pause between two pulses must be at least as long as the pulse, the repetition rate is
automatically adjusted to take account of this.

The emitted pulse peak power, the overall number of pulses emitted (Counter) and the total energy
emitted (Energy) are shown in the display.

9.5.1.3          Setting the brightness of the pilot laser / aiming beam

The brightness of the pilot laser / aiming beam (635 nm emission wavelength) can be adjusted in the
CONTINOUS, PULSED or SINGLE menu by choosing aiming beam and turning the adjusting wheel
between 0 and 100%. Maximum setting (= 100 %) is 0.95 mW from the orderly fiber. The pilot laser is
ON in the Ready state. After switching on the system the brightness of the pilot laser is automatically
set to 30 % whenever the setting was below 30 % before switching off the system. Otherwise the set
value is kept.

9.6        Switch-off routine

1.     Switch off the laser system with the key switch. The fibers may remain connected. All settings
       are retained for the next time it is used.

2.     Take off laser safety goggles.

3.     Pull out the mains connector.

4.     Remove the key, to prevent unauthorized use of the system.

9.7       Orderly state of the laser system

The laser system is in its orderly state if:

1. after switch on first the start display and then the parameter menu appears,

2. the maximum adjustable power corresponds with the value on the name plate,

3. a fiber which is in a orderly state emits power during operation of the laser.




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10 Clinical applications
The following text is based on the experiences of users of RevoLix medical 2 µm continuous wave
lasers and international publications concerning the use of medical lasers. This literature is available to
interested parties on request. Please make yourself aware of the content of this section before you use
the laser clinically. Start your experience of lasers with low power settings for safety reasons.

The given parameters are provided as a guide. Adjust the parameters individually according to your
treatment experiences, clinical observations and the laser-tissue interaction.

Take note of the relevant safety regulations (section 7 ”Laser and device safety”) and follow the
instructions of your establishment‟s laser safety officer.

                   Whenever a laser or specifically a RevoLix system is used there is a potential risk
                   of thermal damage. Start with low power settings. The laser should only be
                   activated if the fiber tip and the tissue at which the laser is directed is within sight.

   DANGER
10.1      Urology

The RevoLix laser is used in urology in the following clinical applications:

Removal of urethral strictures

Removal of ureter strictures

Resection of the prostate

Bladder neck incisions

In-situ ablation of bladder tumors

Condylomata


                   With all applications of the RevoLix laser in the urogenital tract there is a danger of
                   perforation. Therefore the laser may only be switched on if the distal tip of the fibre
                   and its effect to tissue is under visual control of the surgeon controlling the foot
                   switch. Start with low power settings.
    DANGER

The tissue effects of the RevoLix medical 2 µm continuous wave laser are particularly advantageous in
endourological application.

LISA laser products OHG supplies the necessary laser fibers as standard accessories. The
endoscopic urological instruments, which are required in addition, must have a working channel to take
the laser fiber and need to be authorized by the manufacturer for the use together with lasers or At
best with the RevoLix product. Please allow us to advise you.

The laser fibers described in this section are reusable. Information about sterilization can be found on
the packaging and in the laser fiber user manual. It is preferable to choose a sterilization process,
which operates at the lowest possible temperatures (< 90°C) in order to exclude oxidization of the fiber
connector. By principle autoclaves operate at 121°C minimum temperature. Therefore this method of
sterilization should not be used as standard if repeated use of fibers is intended.

The laser fibers described in this section emit the laser radiation forwards. The fibers must be checked
if they are in orderly state before they are used. If the tip of the fiber is not in orderly state the distal end
needs to be cut with the fiber tool. After shortening the beam quality should be checked with the pilot
laser.

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10.1.1 Opening of urethral strictures

Laser accessories:                PercuFib laser fiber
                                  Laser resectoscope

Laser setting:

                        Power setting          5 - 15 W

                        Mode                   Continuous


Preparation:

Prepare the laser system according to section “Operation of the laser system”.

Make sure before the procedure that the existing fibers are compatible with the endoscopic instrument
to be used.

Take care that the fibers can easily be introduced into the endoscopic instrument and taken out again.
Check that the laser fiber can be fixed in the applicator. The distal fiber end must be able to be brought
into the field of vision of the optic.

Procedure:

1. Start the laser as described in the section on “Operation of the laser system”.

2. Insert the fiber in the endoscopic instrument. The non-sterile nurse attaches the fiber to the laser.

3. Check if the red pilot laser is emitted at full strength from the fiber. If it seems weak it could be that
   the fiber was damaged during insertion into the instrument. In this case the fiber should be
   prepared again using the fiber tool or different fiber should be used. If a damaged fiber is used, this
   can lead to severe damage and burns.

4. At the begin use a low power setting; e.g. 5 – 10 Watts.

5. Use the “contact” method for incision. Activate the laser with the foot switch while pulling the fiber
   tip backwards across the tissue surface. It is advantageous to do so, because in this way the risk
   to perforate the tissue is minimum.

6. Adjust the power setting in the light of your experience.




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10.1.2 Opening of ureter strictures

Laser accessories:                PercuFib laser fiber
                                  Ureterorenoscope

Laser setting:

                        Power setting          5 – 10 W

                        Mode                   Continuous


Preparation:

Prepare the laser system according to section “Operation of the laser system”.

Make sure before the procedure that the existing fibers are compatible with the ureterorenoscope to be
used.

Take care that the fibers can easily be introduced into the ureterorenoscope and taken out again.
Check that the laser fiber can be fixed. The distal fiber end must be able to be brought into the field of
vision of the optic.

Procedure:

1. Start the laser as described in the section on “Operation of the laser system”.

2. Insert the fiber in the endoscopic instrument. The non-sterile nurse attaches the fiber to the laser.

3. Check if the red pilot laser is emitted at full strength from the fiber. If it seems weak it could be that
   the fiber was damaged during insertion into the instrument. In this case the fiber should be
   prepared again using the fiber tool or different fiber should be used. If a damaged fiber is used, this
   can lead to severe damage and burns.

4. At the begin use a low power setting; e.g. 5 Watts.

5. Use the “contact” method for incision. Activate the laser with the foot switch while pulling the fiber
   tip backwards across the tissue surface. It is advantageous to do so, because in this way the risk
   to perforate the tissue is minimum.

6. Adjust the power setting in the light of your experience.




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10.1.3 Resection of the prostate

Laser accessories:               PowerFib laser fiber,
                                 Laser resectoscope,
                                 sterile fiber tool or 2-3 spare fibers

Laser setting:

                        Power setting         20 – 40 W

                        Mode                  Continuous


Preparation:

Prepare the laser system according to section “Operation of the laser system”.

Make sure before the procedure that the existing fibers are compatible with the laser resectoscope to
be used.

Take care that the fibers can easily be introduced into the laser resectoscope and taken out again.
Check that the laser fiber can be fixed. The distal fiber tip must be able to be brought into the field of
vision of the optic.

The cladding of the laser fiber acts as mechanical reinforcement and protection against kinking and
breaking at the distal end of the laser resectoscope. For this reason only the cladding protruding from
the fiber guidance tube should be removed, i.e. only 3 – 5 mm. When the fiber is inserted into the
resectoscope the cladding at the distal end of the guidance tube must be visible.

Procedure:

1. Start the laser as described in the section on “Operation of the laser system”.

2. Insert the fiber into the instrument. The non-sterilized nurse attaches the fiber to the laser.

3. Check if the red pilot laser is emitted at full strength from the fiber. If it seems weak to you it could
   be that the fiber was damaged during insertion into the instrument. In that case the fiber should be
   prepared again using the fiber tool or another fiber should be used. If a fiber, which is broken
   inside the instrument, is used, this can lead to severe damage and burns.

4. At the begin use a low power setting; e.g. 20 to 30 W.

5. Use the “near contact” method for resection. Activate the laser with the foot switch while pulling the
   fiber end back or sideways across the tissue surface. It is advantageous to do so, because in this
   way the fiber end cannot remain hanging in the tissue.

6. Today different methods of resection of prostate are applied. You will find a detailed description of
   the technique used with Holmium lasers in: Peter J. Gilling, “The Technique of Holmium-Laser
   Resection of the Prostate (HOLRP)”. These guidelines may be used with the RevoLix as well. A
   different approach is the enucleation of the prostate where the lobes are enucleated with a
   remaining connection to the bladder neck. some contact to the until they are connected Later the
   lobes are removed with help of a mechanical punch. A systematic method of working is a good
   prerequisite for a successful resection.

7. Adjust the power setting in the light of your experience.

8. Change or cut the fibers when you feel the cutting effect is impaired.




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10.1.4 Bladder neck incisions

Laser accessories:               PowerFib laser fiber,
                                 Laser resectoscope

Laser setting:

                        Power setting         15 – 25 W

                        Mode                  Continuous


Preparation:

Prepare the laser system according to section “Operation of the laser system”.

Make sure before the procedure that the existing fibers are compatible with the laser resectoscope to
be used.

Take care that the fibers can easily be introduced into the laser resectoscope and taken out again.
Check that the laser fiber can be fixed. The distal fiber tip must be able to be brought into the field of
vision of the optic.

The cladding of the laser fiber acts as mechanical reinforcement and protection against kinking and
breaking at the distal end of the laser resectoscope. For this reason only the cladding protruding from
the fiber guidance tube should be removed, i.e. only 3 – 5 mm. When the fiber is inserted into the
resectoscope the cladding at the distal end of the guidance tube must be visible.

Procedure:

1. Start the laser as described in the section on “Operation of the laser system”.

2. Insert the fiber into the instrument. The non-sterilized nurse attaches the fiber to the laser.

3. Check if the red pilot laser is emitted at full strength from the fiber. If it seems weak to you it could
   be that the fiber was damaged during insertion into the instrument. In that case the fiber should be
   prepared again using the fiber tool or another fiber should be used. If a fiber, which is broken
   inside the instrument, is used, this can lead to severe damage and burns.

4. At the begin use a low power setting; e.g. 15 W.

5. Use the “near contact” method for incision. Activate the laser with the foot switch while pulling the
   fiber end sideways across the tissue surface. It is advantageous to do so, because in this way the
   fiber end cannot remain hanging in the tissue.

6. The surgical procedure is almost identical to the regular “Turner Warwick” procedure.

7. Adjust the power setting in the light of your experience.




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10.1.5 In-situ ablation of bladder tumors

Laser accessories:               PowerFib laser fiber,
                                 Laser resectoscope

Laser setting:

                        Power setting         10 – 20 W

                        Mode                  Continuous

Preparation:

Prepare the laser system according to section “Operation of the laser system”.

Make sure before the procedure that the existing fibers are compatible with the laser resectoscope to
be used.

Take care that the fibers can easily be introduced into the laser resectoscope and taken out again.
Check that the laser fiber can be fixed. The distal fiber tip must be able to be brought into the field of
vision of the optic.

The cladding of the laser fiber acts as mechanical reinforcement and protection against kinking and
breaking at the distal end of the laser resectoscope. For this reason only the cladding protruding from
the fiber guidance tube should be removed, i.e. only 3 – 5 mm. When the fiber is inserted into the
resectoscope the cladding at the distal end of the guidance tube must be visible.

Procedure:

1. Start the laser as described in the section on “Operation of the laser system”.
2. Insert the fiber into the instrument. The non-sterilized nurse attaches the fiber to the laser.
3. Check if the red pilot laser is emitted at full strength from the fiber. If it seems weak to you it could
   be that the fiber was damaged during insertion into the instrument. In that case the fiber should be
   prepared again using the fiber tool or another fiber should be used. If a fiber, which is broken
   inside the instrument, is used, this can lead to severe damage and burns.
4. At the begin use a low power setting; e.g. 10 W.
5. Use the “near contact” method for incision. Activate the laser with the foot switch while pulling the
   fiber end sideways across the tissue surface. It is advantageous to do so, because in this way the
   fiber end cannot remain hanging in the tissue. It is possible to undercut or to ablate the tissue.
6. Adjust the power setting in the light of your experience.




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10.1.6 Condylomata

Laser accessories:                PercuFib laser fiber
                                  SlimLas laser handpiece

Laser setting:

                        Power setting          5 - 15 W

                        Mode                   Pulsed,

                                               100 to 400 msec, or

                                               Continuous


Preparation:

Prepare the laser system according to section “Operation of the laser system”.

Make sure before the procedure that the existing fibers are compatible with the laser handpiece to be
used.

Take care that the fibers can easily be introduced into the laser handpiece and taken out again. Check
that the laser fiber can be fixed in the applicator.

Procedure:

1. Start the laser as described in the section on “Operation of the laser system”.

2. Insert the fiber in the laser handpiece. The non-sterile nurse attaches the fiber to the laser.

3. Check if the red pilot laser is emitted at full strength from the fiber. If it seems weak it could be that
   the fiber was damaged during insertion into the instrument. In this case the fiber should be
   prepared again using the fiber tool or different fiber should be used. If a damaged fiber is used, this
   can lead to severe damage and burns.

4. Understand this procedure is carried out in an gaseous medium (air) and charring will be stronger
   compared to endourological cases. At the begin use a low power setting; e.g. 5 – 10 Watts.

5. Use the “contact” method for ablation of condylomata. Activate the laser with the foot switch while
   pointing in near contact at the tissue to be ablated. Immediate blanching indicates the coagulation
   of the tissue.

6. Adjust the power setting in the light of your experience.




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10.2      Gynecology

The RevoLix laser is used in Gynecology in the following clinical applications:

Incisions and excisions to the outer female genital

Condylomata

Laparoscopic procedures are under investigation.

The tissue effects of the RevoLix medical 2 µm continuous wave laser are particularly advantageous in
gynecological application.

LISA laser products OHG supplies the necessary laser fibers and handpieces as standard
accessories. All instruments must have a working channel to guide the laser fiber properly and need to
be authorized by the manufacturer for the use together with lasers or at best with the RevoLix product.
Please allow us to advise you.

The laser fibers described in this section are reusable. Information about sterilization can be found on
the packaging and in the laser fiber user manual. It is preferable to choose a sterilization process,
which operates at the lowest possible temperatures (< 90°C) in order to exclude oxidization of the fiber
connector. By principle autoclaves operate at 121°C minimum temperature. Therefore this method of
sterilization should not be used as standard if repeated use of fibers is intended.

The laser fibers described in this section emit the laser radiation forwards. The fibers must be checked
if they are in orderly state before they are used. If the tip of the fiber is not in orderly state the distal end
needs to be cut with the fiber tool. After shortening the beam quality should be checked with the pilot
laser.


                   With all applications of the RevoLix laser in the urogenital tract there is a danger of
                   perforation. Therefore the laser may only be switched on if the distal tip of the fibre
                   and its effect to tissue is under visual control of the surgeon controlling the foot
                   switch. Start with low power settings.
   DANGER




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10.2.1 Incisions and excisions to the outer female genital

Laser accessories:                PercuFib laser fiber
                                  SlimLas laser handpiece

Laser setting:

                        Power setting          15 – 25 W

                        Mode                   Continuous


Preparation:

Prepare the laser system according to section “Operation of the laser system”.

Make sure before the procedure that the existing fibers are compatible with the laser handpiece to be
used.

Take care that the fibers can easily be introduced into the laser handpiece and taken out again. Check
that the laser fiber can be fixed in the applicator.

Procedure:

1. Start the laser as described in the section on “Operation of the laser system”.

2. Insert the fiber in the laser handpiece. The non-sterile nurse attaches the fiber to the laser.

3. Check if the red pilot laser is emitted at full strength from the fiber. If it seems weak it could be that
   the fiber was damaged during insertion into the instrument. In this case the fiber should be
   prepared again using the fiber tool or different fiber should be used. If a damaged fiber is used, this
   can lead to severe damage and burns.

4. Understand this procedure is carried out in an gaseous medium (air) and charring will be stronger
   compared to endourological cases. At the begin use a low power setting; e.g. 15 Watts.

5. Use the “near contact” method for incision. Activate the laser with the foot switch while pulling the
   fiber end sideways across the tissue surface. It is advantageous to do so, because in this way the
   fiber end cannot remain hanging in the tissue. It is possible to undercut or to ablate the tissue.

6. Adjust the power setting in the light of your experience.




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10.2.2 Condylomata

Laser accessories:                PercuFib laser fiber
                                  SlimLas laser handpiece

Laser setting:

                        Power setting          5 - 15 W

                        Mode                   Pulsed,

                                               100 to 400 msec, or

                                               Continuous

Preparation:

Prepare the laser system according to section “Operation of the laser system”.

Make sure before the procedure that the existing fibers are compatible with the laser handpiece to be
used.

Take care that the fibers can easily be introduced into the laser handpiece and taken out again. Check
that the laser fiber can be fixed in the applicator.

Procedure:

1. Start the laser as described in the section on “Operation of the laser system”.

2. Insert the fiber in the laser handpiece. The non-sterile nurse attaches the fiber to the laser.

3. Check if the red pilot laser is emitted at full strength from the fiber. If it seems weak it could be that
   the fiber was damaged during insertion into the instrument. In this case the fiber should be
   prepared again using the fiber tool or different fiber should be used. If a damaged fiber is used, this
   can lead to severe damage and burns.

4. Understand this procedure is carried out in an gaseous medium (air) and charring will be stronger
   compared to endourological cases. At the begin use a low power setting; e.g. 5 – 10 Watts.

5. Use the “contact” method for ablation of condylomata. Activate the laser with the foot switch while
   pointing in near contact at the tissue to be ablated. Immediate blanching indicates the coagulation
   of the tissue.

6. Adjust the power setting in the light of your experience.




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11 Error messages

11.1     Error menu

Throughout the period that the system is in operation continuous checks are carried out which, should
they prove negative, give rise to warnings or errors. Every irregularity recognized by the system
processor is displayed in clear text on the screen with a three-digit number, together with information
on how to deal with it. Errors clear themselves once the cause is removed. Afterwards the laser must
be released with the „ready‟ button.

If it is not possible to correct a error, the service technician must be informed. You will find the
telephone number of your service technician in the section ”Technical Data”.

The error messages look like this:




                   Fig. 27: System menu with error message 013 (Interlock open)

11.2     List of error messages

The following errors are recognized by the system and displayed. In cases of repetition the service
technician should be informed about the error messages, which have appeared, before his visit.

All errors are to be listed in the medical systems book and passed on to the manufacturer.

We should be grateful if you would let us know your experiences with our laser. We can deduce
valuable information for the further development of our systems particularly from difficulties you may
have encountered during use and the possible solutions you have found.
  No.            Error message                     Explanation               Remedial measure
  001    High temperature of cooling       High temperature of the      Allow the laser to cool down –
         system                            cooling water.               do not switch off. Be sure to
                                                                        operate the laser at no more
         Please wait for cool down !
                                                                        than 28°C ambient temp. Do
                                                                        not cover air vents.
  002    High temperature of laser         High temperature of the      Allow the laser to cool down –
         power supply.                     laser power supply.          do not switch off. Be sure to
                                                                        operate the laser at no more
         Please wait for cool down !
                                                                        than 28°C ambient temp. Do
                                                                        not cover air vents.
  003    Error message of                  Internal error               Restart laser system.
         microprocessor.
         Please restart system !


  004    Failure of pulse generator        Internal error               Restart laser system or call

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  No.               Error message                   Explanation                   Remedial measure
         Please call service engineer !                                      service engineer if error
                                                                             condition persists.
  005    Failure of low voltage power       The low voltage power            Restart laser system or call
         supply                             supply for microprocessors       service engineer if error
                                            and electronics may be           condition persists.
         Please call service engineer !
                                            defective.
  006    Power line failure                 Mains supply may be out of       Please have the mains supply
                                            range or the power line is       checked by an electrician or
         Please check power line !
                                            defective.                       call service engineer if error
                                                                             condition persists.
  007    Cooling water flow failure         The cooling water flow rate      Restart laser system or call
                                            is low.                          service engineer if error
         Please call service engineer !
                                                                             condition persists.
  008    Cooling water level failure        The level of the cooling         The laser should continue to
                                            water is low. Reason may         operate. However the service
         Please call service engineer !
                                            be leakage or evaporation.       engineer should be called
                                                                             immediately to check the
                                                                             system.
  009    Chiller failure                    Error condition in the chiller   Restart laser system or call
                                            module.                          service engineer if error
         Please restart system !
                                                                             condition persists.
  010    Detector failure                   Error condition in the power     Restart laser system or call
                                            detectors.                       service engineer if error
         Please call service engineer !
                                                                             condition persists.
  011    Laser Stop button pressed          Laser Stop button was            Release Laser Stop button by
                                            activated.                       turning it anti-clockwise.
         Please release Laser Stop
         button !
  012    No fiber                           The laser fiber connector is     Attach the laser fiber and
                                            detected if fully inserted.      secure the connector finger
         Please connect fiber !
                                            The laser will not operate       tight. Call service engineer if
                                            until fiber is orderly           error condition persists.
                                            connected.
  013    Interlock open                     Interlock circuit open or        Check interlock circuit or
                                            dummy connector missing.         attach dummy connector.
         Please check interlock circuit !
  014    Footswitch failure                 Footswitch signals not           Check footswitch connector.
                                            synchronized.                    May be the footswitch was
         Please check the footswitch
                                                                             depressed extremely. Press
         connector !
                                                                             faster.



  015    Footswitch not connected           Footswitch not detected by       Connect footswitch.
                                            laser system.
         Please connect footswitch !




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12 Care and maintenance
This section will be devoted solely to measures, which appertain to the maintenance of the laser
system‟s functional capability. This section is not a repair or service manual!

12.1     Cleaning

The laser system does not require any particular maintenance on the part of the user. Surface cleaning
using a damp cloth with a noncaustic cleaning solution like suds, an alcohol solution or a disinfectant
may be undertaken. When doing this take care that no moisture can penetrate into the fiber port. Do
not use any alcoholic solution to clean the display.

12.2     Technical safety control and maintenance

Every 12 months the laser system should undergo a technical safety control and maintenance by a
service technician authorized by the manufacturer to ensure proper laser performance.

12.3     Calibration of the energy and power displays

The displayed value for power shown on the screen display are based on values, taken directly from
the laser resonator. The values are reduced by a fixed factor, which takes into account for the
transmission loss of an optimum transmission system (fiber). Below will be described how the power
reading on the screen display can be calibrated. In normal use this calibration is unnecessary.

With the external laser power meter it is possible to determine the power emitted from the fiber tip by a
given fiber. The calibration factor for the power reading on the screen display is determined as follows:

    Calibration factor = Reading of the external laser power meter / Power reading on laser display

If the power deviation is greater than 20% then call your authorized LISA service center in order to
arrange a calibration of the laser system.

The power emitted from the transmission system is corrected for each setting in accordance with the
following formula:

                      Power = Calibration factor * Power reading on laser display

The transmission properties of a fiber are highly dependent upon the condition of both ends of the
fiber. The unavoidable burning off of the distal fiber end can reduce the transmission to 50%.
Evaluation and, if necessary, shortening of the distal fiber end are explained in the relevant accessory‟s
manual.

12.4     Use of the external power meter

The external power meter can be obtained from the manufacturer of the RevoLix (Section 16
“Accessories for RevoLix”).

The pilot laser should be set to maximum brightness and an orderly fiber attached to the laser (section
9.2.2 "Connecting the fiber"). Before activating the laser all persons present in the laser area must
wear appropriate safety goggles. The laser is activated by a foot switch, whilst the laser fibers pointed
downwards. In doing this care is taken that persons are not endangered and that the laser beam does
not cause unnecessary or dangerous heating of material.

With your free hand press the reset-knob on the power meter for 2 seconds, after which the black
absorbent surface is brought into the laser beam. The red spot of the pilot laser should cover about 2/3
of the absorbent surface. If the measuring system gives out a series of three signal tones, the
measurement is complete and the foot switch is released. The power meter displays the measurement
obtained in watts for several seconds. Then, after a more rapid tone sequence, it returns to its rest
position.



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13 Decontamination of Returned Equipment
To comply with the U.S. postal and transportation laws, equipment shipped to AllMed Systems Inc for
repair or return must be properly decontaminated with a chemical germicide that is commercially
available and cleared for use as a "Hospital Disinfectant." To ensure that all equipment has been
properly decontaminated, a signed Decontamination Certificate (provided at the end of this section)
must be enclosed in the package.

If equipment is received without a Decontamination Certificate, AllMed Systems will assume that the
product is contaminated and will assess the customer with cleaning costs.

Any inquiries should be directed to AllMed Systems Medical Service Department.

                                            AllMed Systems Inc.
                                            9232 Klemetson Dr.
                                           Pleasanton, California
                                                94588 USA
                                            Fon: (925) 469 0433
                                            Fax: (925) 399 5984

For service assistance and to order replacement parts or accessories, call AllMed Systems Service /
Customer Relations at the following telephone number: 925 468 0433




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                          DECONTAMINATION CERTIFICATION


Under the provisions of Postal Law, Title 18, United States Code, Section 1716, and Department of
Transportation rules contained in CFR 49, Section 173.386 and 173.387, "etiologic agents, diagnostic
specimens and biological products... are non-mailable..."



The undersigned therefore certifies that the AllMed Systems equipment being returned herein by




__________________________                 __________________________
Individual/Institution                     City/State

has undergone decontamination with a commercially available germicide cleared for use as a "Hospital
Disinfectant" and is clean and free from biohazards, including, but not limited to, human or animal
blood, tissue or tissue fluids or components thereof.

The undersigned also agrees to reimburse AllMed Systems for any costs incurred in cleaning the
enclosed equipment, in the event said item(s) is/are received by AllMed Systems in a contaminated
condition.



______________________________
Model



______________________________
Serial Number



______________________________
AllMed Systems RMR Number



______________________________                    ___________________________
Printed Name                                      Position/ Title




______________________________                    ___________________________
Signature                                         Date




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14 Technical data
The following pages contain technical data relating to the laser system supplied with this manual.



Manufacturer:             LISA laser products OHG
                          Max-Planck-Str.1
                          D-37191 Katlenburg-Lindau
                          Germany
                          Fon     +49 (0) 5556-9938-0
                          Fax     +49 (0) 5556-9938-10
                          e-mail: info@lisalaser.de
                          web: www.lisalaser.com




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                                     No text on this page.




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15 Technical data RevoLix
Technical entity                            Type
Laser type                                  Diode pumped solid state laser (DPSS)
Laser safety class                          4 & 2 (pilot laser)
Emission wavelength                         2.01 µm
Maximum power                               90 W
Operational mode                            Continuous wave (cw), pulsed (chopped)
Duration                                    50 ms to cw
Aiming beam (pilot laser)                   Semiconductor laser, 635 nm, < 1 mW
Mains voltage                               230 VAC, -13 %, +10 %
Mains current at 230 VAC                    Max. 13 A
Storage ambient temperature                 +3°C to 45°C
Operational ambient temperature             +18°C to 28°C
Cooling system                              Integrated, refrigerant
Refrigerant                                 R134 A
Heat emission (peak)                        3 kW
Heat emission (average)                     App. 2 kW
Dimensions (Depth x width x height)         0.89 x 0.42 x 0.95 m
Weight                                      App. 140 kg




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16 Accessories for RevoLix
The laser system may only be used with the following accessories:
Description                                                          LISA order                Article no.
                                                                     designation
Personal protective equipment
                                                                                              101 503 142
Colour neutral laser safety glasses for RevoLix with earpieces                               640,00
Colour neutral laser safety goggles for RevoLix without earpieces                             101 503 143
General Surgery
Standard hand applicator, straight                                   SlimLas                  101 503 106
Standard hand applicator, 15°                                        SlimLas 15°              101 503 107
Standard hand applicator, 30°                                        SlimLas 30°              101 503 136
Cleaning wire for SlimLas                                            Cleaning wire 0.7 mm     101 503 111
Laser handpiece for ENT                                              ENTLas                   101 503 167

PercuFib fiber (365 µm optical core)                                 PercuFib                 101 503 128

Fiber repair tools
Stripping tongs for PercuFib                                         Fiber-Stripper 0.5       101 503 129
Fiber cutter for fiber cleaving                                      Fiber cutter             101 503 110

Laser accessories:
Inspection microscope for fiber connector                            Inspection microscope 101 503 145
Laser power meter                                                    PED                      101 503 140



Attention is specifically drawn to the fact that only laser fibers supplied by the laser manufacturer (LISA
laser products OHG) may be connected to the laser system. So-called SMA compatible products made
by other manufacturers could cause costly damage to the laser optics in the fiber coupler.

Additional accessories to be used must be specifically certified by the accessory manufacturer as
being compatible for use with the RevoLix

Please ask the laser manufacturer about additional accessories available for the system.




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17 Conformity declaration
The following pages contain the conformity declaration, with which the manufacturer states that the
laser system described in this manual conforms with the 93/42/EEC guideline on medical products.




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18 ISO certificates
The following page contains a copy of the DIN EN ISO 9001 and EN ISO 13485 certificate issued by
the TÜV Product Service, Munich for LISA laser products OHG.




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19 Index
                                                                                  Laser diode ........................................................... 17
A
                                                                                  Laser parameters .................................................. 40
Accessories........................................................... 67         Laser safety goggles ............................................. 29
Aiming beam ........................................................ 23           Laser safety officer ............................................... 30
Authorised users of the laser device ..................... 30                     Laser warning lamp ........................................ 36, 39
                                                                                  Laser warning light ........................................ 24, 32
C
                                                                                  M
Calibration of the energy and power displays ...... 57
Care and maintenance .......................................... 57                Marking of entrance doors ................................... 24
Checking the laser fiber........................................ 37               Marking the operating room................................. 32
Classifications ...................................................... 15         Medical devices book .......................................... 30
Clinical applications ............................................. 45            module latches ..................................................... 31
Coagulative .......................................................... 18         Moses effect ................................................... 19, 21
Cooling ................................................................. 32
                                                                                  N
cooling water ........................................................ 31
CW ....................................................................... 17     Name plate ........................................................... 26
D                                                                                 O
Damage zone ........................................................ 19           Operating console .......................................... 17, 36
Diode pumped ...................................................... 17            Operation of the laser device ............................... 35
Disconnecting the fibre ........................................ 38               Operational fault .................................................... 7
Display ................................................................. 40      Operational states ................................................. 40
Divergent.............................................................. 20        Orderly state of the laser device ........................... 43
Door interlock ...................................................... 33
                                                                                  P
DPSS .................................................................... 17
                                                                                  Penetration ........................................................... 17
E
                                                                                  Pilot laser ............................................................. 23
Evaporation .......................................................... 18         Pilot laser brightness ............................................ 43
                                                                                  Pulsed mode ......................................................... 17
F
                                                                                  R
Flashlamp ............................................................. 19
Foot switch ............................................... 33, 36, 39            Risk of injury ......................................................... 7
G                                                                                 S
Glycine ................................................................. 21      Safety instructions .................................................. 7
Gynecology .......................................................... 52          Sodium Chloride solution .................................... 21
                                                                                  Switch-on routine ................................................. 38
H
                                                                                  Symbols.................................................................. 7
Holmium lasers .................................................... 19
                                                                                  T
I
                                                                                  Technical safety control ....................................... 57
Installation............................................................ 31       Transportation and storage ................................... 31
Intended use ......................................................... 19         Treatment parameters ........................................... 20
Intensity................................................................ 18
                                                                                  U
L
                                                                                  Urology ................................................................ 45
Laser area ............................................................. 24




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